Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease

NCT ID: NCT03095573

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-02-28

Brief Summary

Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration. The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune enteropathy in Western countries, and is usually associated with a good response to the gluten free diet and an excellent prognosis. However, a minority of patients develop complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically improved thank to the availability of capsule endoscopy exploration. The aim of this study was to evaluate detection rate and diagnostic concordance of the axial view capsule and CapsoCam capsules in the same patients.

Detailed Description

The study will involve 25 patients with suspected complicated celiac disease , which for clinical reasons are referred for an evaluation of the small intestine by means of capsule endoscopic in order to screen/identify complications. Furthermore, patients under regular follow-up for a known complication of celiac disease (i.e. refractory celiac disease, ulcerative jejunoileitis) will also be enrolled.

Patients reffered to the Center for Prevention and Diagnosis of celiac disease at the research Hospital "Fondazione Cà Granda Ospedale Maggiore Policlinico" in Milan will be prospectively evaluated and consecutively enrolled in the study.

In agreement with international Guidelines, the diagnosis of celiac disease will be based on Presence of atrophy in the duodenal biopsy sampling (Marsh-Oberhuber type 3) and positive serology or genetic compatibility (in case of seronegative patients at diagnosis).

Patients at high risk of celiac disease complications are defined as

• subjects older than 50 years at the time of celiac disease diagnosis
• subjects with persistence / recurrence of gastrointestinal symptoms after at least 6 months of gluten-free diet
• subjects reporting poor compliance to the gluten-free diet
• subjects with alarm signs at diagnosis or during follow-up.

All enrolled patients will undergo examination of the small bowel by means of both endoscopic capsule devices (the axial-view PillCam SB3 and the lateral-view CapsoCam) on the same day at approximately 3 hours interval from one another, according to a protocol already validated in terms of security in other studies. The order of administration of the two different capsules, will be determined by a specific randomization sequence.

At the end of the examination, recorded data from the capsules will be acquired according to the following steps:

• For the axial-view capsule: removal of the recorder after 10 hours recording and/or after checking that the capsule has reached the cecum. The patient will also be instructed to retrieve the capsule from the stools in the hours / days following the examination as per standard protocol.
• For the lateral-view capsule, the patient will be given a specific kit for its retrieval and conservation. The recorded data will be downloaded after retrieval of the capsule.

The 50 videos will be reviewed by three experts operators (L.E., F.B. G.E.T.), blinded and in randomized order. The operators will evaluate the number of lesions detected by the two different types of capsule system (Primary endpoint) and the mean extension of the lesions detected, expressed as percentage of the total transit time of the capsule in the small intestine (Secondary endpoint)

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Lateral-viewing capsule

Examination of the small bowel by means of the lateral-viewing CapsoCam device

Group Type: EXPERIMENTAL

Lateral-viewing CapsoCam device

Intervention Type: DEVICE

Small bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device

Axial-viewing capsule

Examination of the small bowel by means of the axial-viewing capsule

Group Type: ACTIVE_COMPARATOR

Axial-viewing capsule

Intervention Type: DEVICE

Small bowel capsule endoscopy examination with the Axial-viewing capsule device

Interventions

Lateral-viewing CapsoCam device

Small bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device

Intervention Type: DEVICE

Axial-viewing capsule

Small bowel capsule endoscopy examination with the Axial-viewing capsule device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients with celiac disease at high risk of complication (see above for a detailed description)

Exclusion Criteria

• presence of Pacemaker or Defibrillator
• suspected small bowel obstruction
• impaired swallowing
• pregnancy
• presence of contraindications to a capsule endoscopy examination

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Luca Elli

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Elli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy

Locations

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

Site Status: RECRUITING

Irccs Policlinico San Donato

San Donato Milanese, MI, Italy

Site Status: ACTIVE_NOT_RECRUITING

Countries

Italy

Central Contacts

Luca Elli, MD, PhD

Role: CONTACT

lucelli@yahoo.com

+390255033384

Federica Branchi, MD

Role: CONTACT

federica.branchi@gmail.com

+390255033384

Facility Contacts

Luca Elli, MD, PhD

Role: primary

lucelli@yahoo.com

+390255033384

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Other Identifiers

Capsocam

Identifier Type: -

Identifier Source: org_study_id